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Different Exercise Modalities in Chronic Kidney Disease: A Longitudinal Intervention Study

6 november 2026 uppdaterad av: China Institute of Sport Science

A Randomized Controlled Trial of Different Exercise Modalities in Patients With Chronic Kidney Disease: A Longitudinal Study of Renal Outcomes and Potential Mechanisms

This study compares the effects and safety of aerobic, resistance, and combined exercise versus routine health education on renal function, physical function, and quality of life in people with Chronic kidney disease (CKD) over 12 months, while exploring potential mechanisms.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

A total of 120 adults with Chronic kidney disease (CKD) stages G1-G4 will participate in this randomized controlled trial to evaluate the effects and safety of different exercise modalities on renal function, physical function, and quality of life, and to explore potential mechanisms related to renal hemodynamics, inflammation, and oxidative stress. Participants will be randomly assigned to aerobic exercise, resistance exercise, combined exercise, or control groups, with 30 participants planned per group. The study will last 12 months, with assessments at baseline and months 2, 4, 6, and 12.<br> <br> Participants in the exercise groups will complete three approximately 60-minute sessions weekly, including at least one supervised in-person session and remotely monitored sessions. Aerobic exercise will target 55-80% of estimated maximum heart rate. Resistance exercise will use resistance bands and body weight, with intensity adjusted according to individual ability and perceived exertion. The combined group will perform two aerobic and one resistance session weekly. The control group will receive routine CKD health education without structured exercise training during the study.<br> <br> Primary outcomes include renal function and metabolic parameters. Secondary outcomes include physical function, body composition, and quality of life. Exploratory assessments will examine renal hemodynamics, inflammatory markers, oxidative stress, and fibrosis-related biomarkers. Exercise participation and adherence will be monitored, and adverse events will be recorded in all groups. Serious adverse events will be managed according to the study protocol and applicable ethics requirements.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100061
        • Beijing Aerospace General Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år till 60 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

<p style="line-height: 2.5;">

  • Aged 30-60 years, of either sex.
  • Meets the CKD diagnostic criteria in the Kidney Disease: Improving Global Outcomes (KDIGO) guidance and the 2023 Expert Recommendations on the Clinical Pathway for Early Screening of Chronic Kidney Disease (CKD) and Its Complications in Chinese Adults. Two categories of participants will be included: individuals with early-stage CKD, stages G1 and G2, with an estimated glomerular filtration rate (eGFR) of 60-90 mL/min/1.73 m²; and individuals with established CKD, stages G3 and G4, with an eGFR of 15-59 mL/min/1.73 m², who have been assessed by a clinician as able to participate in exercise.
  • Clinically stable, with no dialysis or kidney transplantation within the previous six months.
  • No severe cardiopulmonary dysfunction or other contraindications to exercise.
  • Sufficient cognitive ability to comply with the intervention plan.
  • Willing to participate in the study and provide written informed consent. </p>

Exclusion Criteria:

<p style="line-height: 2.5;">

  • Acute kidney failure; severe hypertension (above 180/110 mmHg); diabetes; heart failure; acute infection; malignancy; or active immune disease.
  • Participation in another clinical trial or structured exercise intervention program within the previous three months.
  • Severe edema, musculoskeletal disease, or other conditions that prevent participation in exercise.
  • Body mass index (BMI)≥35 kg/m².
  • Pregnancy or plans to become pregnant.
  • Severe cognitive impairment or inability to cooperate with the study. </p>

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Aerobic Exercise group

Participants assigned to this group will receive aerobic exercise training.
Övrig: Aerobic Exercise

Participants will undergo aerobic exercise training three times per week for 12 months, with each session lasting approximately 60 minutes. Training will consist primarily of aerobic movements, including high knees, half-squat jumping jacks, boxing steps, V-steps with arm movements, knee lifts with torso rotation, and jumping jacks. Exercise intensity will be targeted at 55%-80% of age-predicted maximum heart rate calculated using the Tanaka formula. Heart rate and session duration will be monitored using a Huawei fitness band. Exercise intensity and difficulty will be individually adjusted according to exercise tolerance and training performance. Progression may involve increasing exercise duration, movement speed, or exercise difficulty. Sessions will include 3-5 minutes of warm-up and 3-5 minutes of cool-down and stretching.
Experimentell: Resistance Training group

Participants assigned to this group will receive resistance training.
Övrig: resistance training

Participants will undergo progressive resistance training three times per week for 12 months, with each session lasting approximately 60 minutes. Training will primarily use resistance bands and bodyweight exercises, including resistance-band chest presses, resistance-band rows, squats, and other exercises adapted to individual physical capacity. Resistance and exercise difficulty will be selected according to baseline exercise capacity and training experience. The target intensity will be adjusted using the rating of perceived exertion (RPE), with participants performing 10-15 repetitions to a level at which the exercise feels substantially effortful. Training will begin with lower resistance and fewer sets, with progressive increases in resistance or sets according to individual tolerance and performance. Exercise completion, resistance, repetitions, fatigue, and discomfort will be recorded throughout the intervention.
Experimentell: Combined Exercise group

Participants assignedto this group will receive combined aerobic andresistance exercise training.
Övrig: Combined Exercise

Participants will undergo combined exercise training three times per week for 12 months, with each session lasting approximately 60 minutes. The weekly program will include two aerobic exercise sessions and one resistance exercise session. Aerobic training will use movements such as high knees, half-squat jumping jacks, boxing steps, V-steps with arm movements, knee lifts with torso rotation, and jumping jacks, with intensity targeted at 55%-80% of age-predicted maximum heart rate calculated using the Tanaka formula. Resistance training will use resistance bands and bodyweight exercises, with intensity adjusted according to the rating of perceived exertion (RPE) and individual exercise capacity. Exercise intensity and difficulty will be progressively adjusted according to tolerance and performance. Heart rate, session duration, exercise completion, and training-related discomfort will be monitored and recorded.
Inget ingripande: control group

Participants received conventional health education.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Estimated glomerular filtration rate
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Estimated glomerular filtration rate will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Renal resistance index
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

The renal resistance index (RI) will be assessed by qualified physicians using Doppler ultrasonography of the bilateral interlobar arteries. Measurements will be obtained at standardized sampling sites in both kidneys, with a sampling gate of 2-4 mm and a Doppler angle of less than 60°.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Serum creatinine
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Serum creatinine will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
The four standard blood lipid parameters
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

The four standard blood lipid parameters, including total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), will be measured using blood samples collected from participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
blood glucose
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

blood glucose will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Urinary protein
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Urinary protein levels will be measured using urine samples collected from participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Urinary albumin-to-creatinine ratio
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

The urinary albumin-to-creatinine ratiowill be measured using urine samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Endogenous Creatinine Clearance
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Endogenous creatinine clearance will be measured using urine samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
6-minute walk test
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Participants will walk as far as possible at their maximum tolerable pace within 6 minutes, and the total distance walked will be recorded.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
30-second sit-to-stand test
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Participants will complete as many sit-to-stand repetitions as possible within 30 seconds, and the total number of completed repetitions will be recorded.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
vital capacity
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Vital capacity will be measured using a standardized spirometer.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
grip strength
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Handgrip strength will be assessed using a calibrated handgrip dynamometer
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Body fat percentage
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Body fat percentage will be measured using an InBody body composition analyzer.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
malondialdehyde
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Malondialdehyde will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
superoxide dismutase
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Superoxide dismutase will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
glutathione peroxidase
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Glutathione peroxidase will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
C-reactive protein
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

C-reactive protein will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
interleukin-6
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

interleukin-6 will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
tumor necrosis factor-α
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Tumor necrosis factor-α will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Interleukin-10
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Interleukin-10 will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Transforming growth factor-β1
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Transforming growth factor-β1 will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
connective tissue growth factor
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Connective tissue growth factor will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Short Form-36 Health Survey
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Short Form-36 Health Survey will be assessed using a questionnaire.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Renal blood flow
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Renal blood flow will be assessed by qualified physicians using ultrasonography.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Peak systolic velocity
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Peak systolic velocity will be assessed by qualified physicians using ultrasonography.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
end-diastolic velocity
Tidsram: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

end-diastolic velocity will be assessed by qualified physicians using ultrasonography.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

China Institute of Sport Science

Samarbetspartners

Beijing Aerospace General Hospital

Utredare

  • Huvudutredare: Bin Zhang, PhD, China Institute of Sport Science

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 november 2026

Primärt slutförande (Beräknad)

15 januari 2028

Avslutad studie (Beräknad)

15 mars 2028

Studieregistreringsdatum

Först inskickad

6 november 2026

Först inskickad som uppfyllde QC-kriterierna

6 november 2026

Första postat (Faktisk)

12 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CISS20250814
  • Project 25-02 (Annat bidrag/finansieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)
  • Project 26-15 (Annat bidrag/finansieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Data will be made available on request.

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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